Assess the Efficacy and Safety of SHR0302 Ointment in Adult Patients With Vitiligo

Phase 2

Terminated

• Conditions: Vitiligo
• Interventions: Drug: Low Dose SHR0302 Ointment BID; Drug: High Dose SHR0302 Ointment BID

• Registration Number: NCT04774809
• Lead Sponsor: Reistone Biopharma Company Limited

Brief Summary

The purpose of this study is to assess the efficacy and safety of SHR0302 ointment in adult patients with Vitiligo.

Detailed Description

This study is a phase II/Ⅲ seamless adaptive clinical trial to evaluate the efficacy and safety of SHR0302 ointment in adult patients with non-segmental vitiligo.

Study Timeline

• Study Start: 2020-01-29
• Study First Submitted: 2021-02-24
• Study First Submitted QC: 2021-02-24
• Study First Posted: 2021-03-01
• Primary Completion: 2022-03-21
• Study Completion: 2022-03-21
• Status Verified: 2022-06
• Last Update Submitted: 2022-07-11
• Last Update Posted: 2022-07-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

1. Subjects who voluntarily signed an informed consent form.
2. Ages at ≥18 and ≤ 65 years
3. Clinical diagnosis of non-segmental vitiligo.
4. All women and men who are likely to give birth must be willing to use at least one efficient method of contraception from the signing of the informed consent form to 1 month after the last dose of IP.
5. Subjects who agree to discontinue all vitiligo-related treatments and camouflage cosmetics with therapeutic effect between screening visit and the last follow-up visit.
6. Subjects who are willing and able to comply with the scheduled visits and treatment plan, laboratory testing and other study procedures.

Exclusion Criteria

1. Subjects who were diagnosed with segmental vitiligo, mixed vitiligo or unclassified vitiligo.
2. Subjects with historical or current evidence of clinically significant disease or lab test abnormalities or with disease that require the administration of prohibited drugs in this study.
3. Subjects with a malignant tumor or a history of malignant tumor (except for fully treated or resected skin non-metastatic basal cell carcinoma or squamous cell carcinoma).
4. Pregnant or lactating female subjects;
5. Subjects who have previously received JAK inhibitors therapy, systemic or oral
6. Subjects who had used any biologics within12 weeks before the baseline or 5 half-lives (whichever is longer).
7. Subjects who participated in other interventional clinical studies within 4 weeks before the baseline visit, or who were still within 5 half-lives of the last dose of the intervention clinical study drug at baseline.
8. Subjects who received a live or live-attenuated vaccination within 8 weeks before the baseline visit.
9. Any other condition that causes the subject to be unfit for the study as per discretion of the investigator.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SHR0302 Low Dose	Low Dose SHR0302 Ointment BID	Drug: SHR0302 SHR0302 Ointment BID Low Dose
SHR0302 High Dose	High Dose SHR0302 Ointment BID	Drug: SHR0302 SHR0302 Ointment BID High Dose

Primary Outcome Measures

Name	Time	Method
Phase 3	24 weeks	Phase 3: Percentage of subjects whose face and neck vitiligo area scoring index improved by at least 75% (F-VASI75) compared with the baseline at week 24.
Phase 2	24 weeks	Phase 2: Percentage of change in face and neck vitiligo area scoring index (F-VASI) compared with baseline at week 24.

Trial Locations

Locations (16)

Wuhan No.1 Hospital; 🇨🇳 Wuhan, Hubei, China

Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China

Ningbo No.2 Hospital; 🇨🇳 Ningbo, Zhejiang, China

The First Affiliated Hospital of Fujian Medical University; 🇨🇳 Fuzhou, Fujian, China

The First Affiliated Hospital of Dalian Medical University; 🇨🇳 Dalian, Liaoning, China

Dermatology Hospital of Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China

West China School of Medicine; 🇨🇳 Chengdu, Sichuan, China

Shanghai Skin Disease Hospital; 🇨🇳 Shanghai, Shanghai, China

Xijing Hospital, Air Force Medical University; 🇨🇳 Xi'an, Shaanxi, China

Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital; 🇨🇳 Tianjin, Tianjin, China

Hangzhou Third Hospital; 🇨🇳 Hangzhou, Zhejiang, China

The First Hospital of Jillin University; 🇨🇳 Changchun, China

Sun. Yai- Sen Memorial Hospital, Sun. Yai- Sen University; 🇨🇳 Guangzhou, China

Zhejiang Provincial People's Hospital; 🇨🇳 Hangzhou, China

Huashan Hospital Affiliated To Fudan University; 🇨🇳 Shanghai, China

Jiangsu Province Hospital; 🇨🇳 Nanjing, China